Corporate report: MHRA-NICE Real-World Evidence Scientific Dialogue

A programme to help decision making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations.

In 2025, the MHRA conducted a Real-World Evidence Scientific Dialogue pilot to assess whether early, structured regulatory engagement could support better evidence generation. This initiative aimed to foster collaboration between regulators and applicants, facilitating robust decision-making for both regulatory and health technology assessment (HTA) purposes.

Following the pilot the MHRA is continuing with RWE Scientific Dialogue through ongoing workshops that enable open discussion on RWE topics whilst continuing to exploring the integration of RWE advice into existing MHRA services. This supports the MHRA’s Data Strategy ambition to promote data-driven innovation and early access to innovative products through RWE and proactive approaches to safety surveillance.

Approximate application window and workshops dates have been added for each MHRA-NICE RWE Scientific Dialogue cycle.

The application window for the first submission cycle of MHRA-NICE RWE Scientific Dialogue has now closed. The Expression of Interest Guidance for MHRA-NICE Real-World Evidence Scientific Dialogue page has been removed.